Breakthrough Devices Program Updates Device Designations Data and Marketing Authorizations List

Jul 13, 2023 | News |

The Breakthrough Devices Program is consistent with the FDA’s mission to protect and promote public health by helping, through a prioritized review, expedite the development, assessment, and review of a device all while considering statutory standards. The voluntary program may be considered for medical devices and device-led combination products that provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.[1] MEDIcept’s white papers outline the program and discuss the manufacturer’s next steps when Breakthrough Device Designation is achieved.[2,3]

The Breakthrough Device Program website was updated for the period January 1, 2023 to March 31, 2023 to capture the following:[4]

  • granted 32 Breakthrough Device designations
  • authorized 5 Breakthrough Devices for marketing

From the launch of the program in 2015 through March 31, 2023 FDA has granted

  • granted 794 Breakthrough Device designations (786 CDRH and 8 CBER)
  • authorized 67 Breakthrough Devices for marketing (65 CDHR and 2 CBER)

MEDIcept is watching the pulse of the Breakthrough Devices Program and will send communications out as the program develops. If you find yourself navigating the Breakthrough Device Designation pathway MEDIcept is here for support. We’ve successfully navigated this process and will drive around common speed bumps.






Melissa Paffenroth – Senior Regulatory Consultant